Cleared Traditional

AGE Automatic Wrist Blood Pressure Monitor (K193628) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193628 · Dongguan E-Test Technology Co., Ltd. · Cardiovascular device
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Jul 2020
Decision
199d
Days
Class 2
Risk

K193628 is an FDA 510(k) clearance for the AGE Automatic Wrist Blood Pressure Monitor. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Dongguan E-Test Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on July 12, 2020 after a review of 199 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Dongguan E-Test Technology Co., Ltd. devices

Submission Details

510(k) Number K193628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2019
Decision Date July 12, 2020
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 125d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 281
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